EP3407771B1 - Aufsatz für ein ureteroskop - Google Patents

Aufsatz für ein ureteroskop

Info

Publication number
EP3407771B1
EP3407771B1 EP17704143.1A EP17704143A EP3407771B1 EP 3407771 B1 EP3407771 B1 EP 3407771B1 EP 17704143 A EP17704143 A EP 17704143A EP 3407771 B1 EP3407771 B1 EP 3407771B1
Authority
EP
European Patent Office
Prior art keywords
sheath
connector
attachment
distal end
imaging device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP17704143.1A
Other languages
English (en)
French (fr)
Other versions
EP3407771A1 (de
Inventor
Timothy P. Harrah
Christopher L. Oskin
Derrick LENZ
Arpita Banerjee
Pavan MISRA
Abhijit Takale
Sandesh GAVADE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Scimed Inc
Original Assignee
Scimed Life Systems Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Scimed Life Systems Inc filed Critical Scimed Life Systems Inc
Publication of EP3407771A1 publication Critical patent/EP3407771A1/de
Application granted granted Critical
Publication of EP3407771B1 publication Critical patent/EP3407771B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00131—Accessories for endoscopes
    • A61B1/00135—Oversleeves mounted on the endoscope prior to insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/00073—Insertion part of the endoscope body with externally grooved shaft
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00105—Constructional details of the endoscope body characterised by modular construction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00112—Connection or coupling means
    • A61B1/00117—Optical cables in or with an endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00112—Connection or coupling means
    • A61B1/00121—Connectors, fasteners and adapters, e.g. on the endoscope handle
    • A61B1/00128—Connectors, fasteners and adapters, e.g. on the endoscope handle mechanical, e.g. for tubes or pipes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/307—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the urinary organs, e.g. urethroscopes or cystoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes

Definitions

  • Embodiments of the present disclosure relate generally to medical devices for providing an access pathway through a patient's urinary tract.
  • a ureteroscopy is an examination of the ureter or kidney of a patient using a ureteroscope.
  • Ureteroscopes typically include a long, thin, flexible portion that can be inserted through the patient's urethra, bladder, and ureteral orifice connecting the bladder and the ureter.
  • Ureteroscopes typically further include a camera and lighting system to adequately visualize the scope's pathway and the working area within the ureter or kidney.
  • a ureteroscopy procedure involves treating a stone that has lodged in the patient's mid to upper ureter or within a calyx of the kidney.
  • a cystoscope Before a ureteroscope can be inserted into a patient's ureter, a separate device called a cystoscope is required to pass through the urethra, examine the bladder, and find the ureteral orifice. An examination of the bladder is called a cystoscopy.
  • the cystoscope includes a separate camera and lighting system, is often shorter than a ureteroscope, and is typically more rigid than a ureteroscope.
  • a guidewire is inserted into the ureter.
  • the cystoscope is then removed from the patient, leaving the guidewire in place.
  • An access sheath is often then inserted over the guidewire through the urethra, bladder, and into the ureter.
  • the guidewire is removed and the ureteroscope can then be inserted through the access sheath and into the ureter.
  • Document DE 3 834 156 A1 discloses the features of the preamble of claim 1 and describes a rigid medical endoscope having a working channel as introduction aid for flexible endoscopes.
  • the rigid endoscope is constructed such that it is splittable over its entire length through the working channel.
  • Document US 4 132 227 A describes a urological endoscope.
  • a hollow cylindrical sheath has a proximal end and a distal end.
  • An optical viewing device is located in the sheath extending from the distal back to the proximal end.
  • An outflow tube is slidable onto the sheath to surround the sheath and form together with the sheath an intermediate return-flow space between the outer wall of the sheath and the inner wall of the outflow tube, with the outflow tube when in position slid over the sheath tightly surrounding the distal end portion of the sheath.
  • Clear rinsing water is introduced into the proximal end of the sheath. Turbid water is removed from the proximal end of the intermediate space.
  • the outflow tube is provided with apertures at the distal end thereof for the flow of clear rinsing water out of the distal end of the sheath and around the end of the endoscope and then through the apertures into the intermediate space.
  • Document US 5 169 397 A describes a medical instrument comprises an operating section and an insertion section connected to the operating section and adapted to be inserted into a living body, the insertion section including a tubular member formed of a liquid crystal polymer.
  • the tubular member constituting the insertion section of the medical instrument or a channel tube disposed in the insertion section is formed thin-walled by using the liquid crystal polymer.
  • the second sheath includes a proximal end, a distal end, and an opening in a wall of the second sheath, wherein the opening extends from the proximal end of the second sheath to the distal end of the second sheath and is configured to permit the second sheath to be pulled away from the first sheath without having to withdraw the first sheath proximally relative to the second sheath.
  • the second sheath includes an elongated shaft having a length of between 50-350 mm and is configured to permit the second sheath to be pulled away from the first sheath without having to withdraw the first sheath proximally relative to the second sheath.
  • a system in accordance with the invention includes an ureteroscope and an attachment for the ureteroscope in accordance with the invention.
  • any of the attachments described herein may include one or more of the following features: the first sheath may include a proximal portion having a larger diameter than a distal portion of the first sheath; the lumen may be a first lumen, and the first sheath may further include a second lumen; the second sheath may include a proximal end, a distal end, and an opening in a wall of the second sheath, wherein the opening extends from the proximal end of the second sheath to the distal end of the second sheath; the second sheath may have a length that is less than a length of the first sheath; the connector may be removably coupled to the first sheath; and the connector may include an elongated body with an interior configured to receive a portion of the imaging device, and on an interior wall, at least one of a liner or a rib, wherein the at least one of the liner or the rib is configured to secure the imaging device relative to the connector.
  • the connector of the attachment may include an interior configured to receive a portion of the imaging device.
  • any of the attachments described herein may include one or more of the following features: the proximal end of the first sheath may have a larger diameter than the distal end of the first sheath; the second sheath may be positioned around an exterior of the first sheath; the second sheath may be secured to the first sheath by a friction fit, and the second sheath may be removably coupled to the first sheath; the connector may include an opening in a side wall adjacent to a distal end of the connector, wherein the opening is configured to receive a tubular member of the imaging device; the connector may be removably coupled to the proximal end of the first sheath; the connector may include a plurality of ribs protruding from an interior wall of the connector; and the connector may include a silicone liner on an interior wall of the connector.
  • a method, which does not form part of the invention, for using an attachment for an imaging device includes inserting a distal end of a tubular member of the imaging device, a distal end of a first sheath, and a distal end of a second sheath through a urethra of a patient and into a bladder of the patient, wherein the second sheath is positioned around an exterior of the first sheath; removing the second sheath from the patient; inserting the distal end of the tubular member and the distal end of the first sheath into a ureter of the patient; and moving the distal end of the tubular member relative to the first sheath.
  • Examples of the present disclosure may include attachments for coupling to an imaging device.
  • the attachment may include one or more sheaths and a connector for coupling the one or more sheaths to the imaging device.
  • the imaging device is a ureteroscope with an imaging system for viewing an interior of a patient.
  • a second sheath is positioned around a distal portion of a first sheath, and the first sheath is coupled to the connector.
  • the attachment may allow a medical practitioner to perform both a cystoscopy procedure and a ureteroscopy procedure using the same camera, lighting, and other equipment.
  • the related methods disclosed in this application which do not form part of the invention, may allow a medical practitioner to eliminate certain steps typically associated with ureteroscopy procedures.
  • FIG. 1 illustrates an attachment 2 according to a first example.
  • the attachment 2 may be coupled to an imaging device 4.
  • the attachment 2 includes a first sheath 6, a second sheath 8, and a connector 10.
  • the first sheath 6 extends from a proximal end to a distal end and may include a proximal portion 14 and an elongated shaft 12.
  • the first sheath 6 may have a length of between 200-700 mm, 250-650 mm, 300-600 mm, or 350-550 mm. If being used for a child, the first 6 sheath may have a length less than 200 mm.
  • the elongated shaft 12 and the proximal portion 14 may be formed as a single component or may be two separate components permanently or removably coupled together.
  • the elongated shaft 12 may extend from a proximal end 16 adjacent the proximal portion 14 to a distal end 18 (see FIG. 2 ).
  • the exterior of shaft 12 may have a diameter of between 1-8 mm, 2-7 mm, 3-6 mm, or 4-5 mm.
  • the proximal portion 14 may expand radially outward relative to the elongated shaft 12 and may have a larger diameter than the elongated shaft 12.
  • the first sheath 6 may include any appropriate biocompatible material, such as polymers, urethane, fluorine-polymer blend, or metals (e.g., stainless steel).
  • the shaft 12 may include a main lumen 20 and a side lumen 22.
  • the main lumen 20 may be configured to receive a tubular member 26 of an imaging device 4, described further below.
  • the side lumen 22 may be configured to receive a guidewire.
  • the first sheath 6 does not include a separate side lumen 22, or the first sheath 6 includes two or more side lumens 22.
  • the first sheath 6 may further include one or more entry ports on the proximal portion 14 to receive one or more guidewires. The entry ports may lead to the main lumen 20 of the first sheath 6 or to the side lumen 22 of the first sheath 6.
  • an imaging device 4 for use with the attachment 2 is a ureteroscope with a camera system.
  • the imaging device 4 may include a handle assembly 24 and a tubular member 26.
  • the proximal end of the tubular member 26 may be connected to the handle assembly 24, as shown in FIG. 4 .
  • a distal portion of the tubular member 26 may be positioned within the main lumen 20 of the shaft 12.
  • the imaging device 4 may further include a variety of other components necessary for viewing the interior of a body, such as camera and lighting equipment.
  • a camera 28 and a light 30 may be located at the distal end of the tubular member 26.
  • Optical fiber cables may be used to transmit light from the proximal end of tubular member 26 to the distal end of tubular member 26.
  • the camera may be coupled to the distal end of the tubular member 26, with power and signal wires extending proximal to the ureteroscope handle 24.
  • the tubular member 26 may include one or more working lumens 32 for tools and irrigation.
  • Working lumen 32 or separate channels in the tubular member 26 may hold the wires and/or fibers connecting the camera 28 and light 30 to a power source, LED, and/or other processing and control equipment, along with mechanical cables to permit maneuverability of the tubular member 26.
  • the inner and/or the outer wall of the proximal portion 14 of the first sheath 6 may expand radially outward and in a proximal direction from the proximal end 16 of the shaft 12.
  • the proximal portion 14 may generally form a funnel shape.
  • the inner and/or outer wall of the proximal portion 14 may be curved.
  • the proximal portion 14 may include a lip 34 at its proximal end.
  • the lip 34 may facilitate connection to the connector 10 in a manner described in more detail below.
  • the lip 34 may include one or more slots 36.
  • the slots 36 may include an elongated shape and may extend partially or fully through the material of lip 34.
  • the slots 36 may receive corresponding protrusions located on the connector 10.
  • the lip may further include one or more slots 38.
  • the slots 38 may similarly extend partially or fully through the material of lip 34 and may receive corresponding protrusions located on the connector 10.
  • the slots 38 may include a bend to facilitate a secure attachment of the sheath 6 to the connector 10.
  • the lip may further include an opening 39, which may extend through the lip 34.
  • the opening 39 may include a generally round shape and may be configured to receive the tubular member 26 of the imaging device 4.
  • the first sheath 6 may include a port 40 for receiving a tubular member 26 of an imaging device 4.
  • the port 40 may include a lumen and may be a proximal extension of the elongated shaft 12.
  • the port 40 may be located within the proximal portion 14 and may be centered within the proximal portion 14. The port 40 may facilitate secure positioning of the tubular member 26 within the first sheath 6.
  • the first sheath 6 does not include a port 40.
  • the inner wall of the proximal portion 14 may serve as a guide for insertion of a tubular member 26 into the shaft 12.
  • a distal end of the tubular member 26 may be inserted into the space within proximal portion 14, and the inner walls of the proximal portion 14 may guide the distal end of the tubular member 26 towards the proximal end 16 of the shaft 12.
  • the proximal portion 14 of the shaft 6 may include a proximal portion of guidewire lumen 22.
  • Guidewire lumen 22 may travel from the inlet shown on the proximal portion 14 of the shaft 6 ( FIG. 5 ), within the wall of proximal portion 14, and down the length of the shaft 12 to the exit at the distal end 18 of the shaft 12 ( FIG. 2 ).
  • the attachment 2 further includes a second sheath 8.
  • the second sheath 8 includes an elongated shaft 42, and may further include a grip 44, a main lumen 46, and a side lumen 48.
  • the elongated shaft 42 of the second sheath 8 may extend from a proximal end 50 to a distal end 52.
  • the elongated shaft 42 has a length of between 50-350 mm, 100-300 mm, or 150-250 mm.
  • the second sheath 8 has a length that is less than the length of the first sheath 6.
  • the exterior of shaft 42 may have a diameter of between 2-10 mm, 3-9 mm, 4-8 mm, or 5-7 mm.
  • the shaft 42 of the second sheath 8 is dimensioned to fit radially outward from and coaxial with the elongated shaft 12 of the first sheath 6 (e.g., the elongated shaft 12 of the first sheath 6 may fit within the main lumen 46 of the second sheath 8).
  • the second sheath 8 is positioned around an exterior of the first sheath 6.
  • the shaft 42 may include any appropriate biocompatible material, such as polymers, urethane, fluorine-polymer blend, or metals (e.g., stainless steel).
  • the shaft 42 of the second sheath 8 may include a main lumen 46 and a side lumen 48.
  • the main lumen 46 may be configured to receive the elongated shaft 12 of the first sheath 6.
  • the side lumen 48 may be configured to receive a guidewire.
  • the second sheath 8 does not include a separate side lumen 48.
  • the second sheath 8 may include a grip 44.
  • the grip 44 may be a protrusion from the elongated shaft 42.
  • the grip 44 may include a first gripping face 54 having a substantially rectangular shape and a second gripping face (not shown) on the opposite side.
  • the thickness of the grip 44 as viewed looking in a proximal direction from the distal end 52 of the shaft 42, may be the grip's smallest dimension.
  • a user may place fingers on the first gripping face 54 and the second gripping face opposite the first face 54.
  • the grip 44 may include first and second gripping faces having any other shape, such as square, circular, ovular, or irregular shapes, or the gripping faces of the grip 44 may be positioned to face the proximal and distal ends of the second sheath 8, instead of facing the sides. Additionally or alternatively, the grip 44 may include a loop, rod, or other structure to facilitate grasping by a user.
  • the shaft 42 of the second sheath 8 includes an opening 56 extending from the proximal end 50 to the distal end 52 of the shaft 42.
  • the opening permits the second sheath 8 to be pulled away from the first sheath 6 without having to withdraw the first sheath 6 proximally relative to the second sheath 8.
  • the second sheath 8 may be pulled by the grip 44 away from the elongated shaft 12 of the first sheath 6 until the elongated shaft 12 exits the lumen 46 of the second sheath 8 through the opening 56 (see FIG. 10 , to be described further below).
  • the material of the second sheath 8 may have sufficient flexibility to allow the material on either side of opening 56 to spread apart, allowing the opening 56 to widen to accommodate the width of elongated shaft 12.
  • FIG. 2 illustrates a perspective view of the distal ends of each of these three components.
  • the elongated shaft 12 of the first sheath 6 may be positioned within the main lumen 46 of the elongated shaft 42 of the second sheath 8.
  • the first sheath 6 may be held in place relative to the second sheath 8 by a friction fit. However, if a user applies force, the friction forces may be overcome and the first sheath 6 or the second sheath 8 may be movable in proximal and distal directions relative to the other sheath.
  • the tubular member 26 may be positioned within the main lumen 20 of the elongated shaft 12 of the first sheath 6. If not fixed in place, the tubular member 26 may be movable in proximal and distal directions relative to the first sheath 6.
  • the attachment 2 may further include a connector 10.
  • the connector 10 may fix the first and second sheaths 6, 8 relative to the imaging device 4.
  • the connector 10 may be removably coupled to the first sheath 6.
  • the connector 10 may be integrally formed with the first sheath 6.
  • the connector 10 may include a body portion 58 having one or more openings 68, 70.
  • the body portion 58 may extend from a proximal end 62 to a distal end 64 and may define a hollow interior configured to receive components of the imaging device 4.
  • the body portion 58 may have a length of between 90-170 mm, 100-160 mm, 110-150 mm or 120-140 mm.
  • the interior of the proximal portion of the body portion 58 may be shaped to fit securely around the exterior of the imaging device 4, such as the LithoVue scope developed by Boston Scientific Corp.
  • the interior of a proximal region 72 of the connector 10 may include a relatively flat upper surface to rest on an upper surface of the imaging device 4, and two curved surfaces to rest against the sides of the imaging device 4.
  • the walls of the connector 10 may include the first opening 68 and the second opening 70.
  • the first opening 68 may be formed in an upper wall of the connector 10 and may extend along a portion of the length of connector 10.
  • the first opening 68 may extend from a location adjacent the proximal region 72 to the distal end 64 of the connector 10.
  • the opening 68 may therefore form a U-shape, with the ends of the U positioned at the distal end 64 of the connector 10.
  • the first opening 68 may allow the user to adjust the placement of the tubular member 26, a portion of which may be positioned within the interior of connector 10.
  • the second opening 70 may be formed in a lower wall of the connector 10.
  • the second opening 70 may generally extend from the proximal end 62 to the distal end 64 of the connector 10, as shown in FIG. 3 .
  • the second opening 70 may be connected to a smaller opening 78 configured to receive the tubular member 26 of the imaging device 4.
  • the tubular member 26 may be able to pass from the second opening 70 to the smaller opening 78 through a passage connecting the two openings.
  • the second opening 70 may provide the connector 10 with flexibility to fit around different models of imaging devices. For example, the width of the second opening 70 may expand to allow the connector 10 to fit around larger imaging devices.
  • the second opening 70 may also allow the tubular member 26 of the imaging device 4 to extend below the connector 10, as shown in FIG. 3 .
  • the second opening 70 may simplify detachment of the connector 10 from the imaging device 4 by allowing the connector 10 to be pulled away from the imaging device 4, with the imaging device 4 passing through opening 70.
  • a lip 66 may be positioned at the distal end 64 of the connector 10.
  • the lip 66 may be an extension of the body portion 58 of the connector 10 and may be configured to mate with the lip 34 of the first sheath 6.
  • the lip 66 may include one or more protrusions 74 configured to mate with slots 36 of the first sheath 6 and one or more protrusions 76 configured to mate with the slots 38 of sheath 6.
  • the lip 66 of the connector 10 may include slots and the lip 34 of the first sheath may include protrusions, or each lip may include a combination of slots and protrusions to facilitate coupling of the two components.
  • the lip 66 may further include an opening 78 configured to receive the tubular member 26 of imaging device 4.
  • the opening 78 of the lip 66 in combination with the opening 39 of the first sheath 6 may secure the tubular member 26 with respect to the attachment 2, which may be useful during medical procedures.
  • the connector 10 and the first sheath 6 may be removably coupled to each other in a manner described further below.
  • the connector 10 may include features to secure the connector 10 to the imaging device 4.
  • the connector 10 may include a strap 60 that connects to each side of the body portion 58 and extends across the second opening 70 and around the bottom of the imaging device 4.
  • the strap 60 may wrap over a port protrusion on the bottom of the imaging device 4, as shown in FIG. 3 .
  • Strap 60 may be an appropriate length to securely hold the imaging device 4 within the interior of the connector 10.
  • Strap 60 may removably connect to one or both sides of the body portion 58 by a snap, a protrusion on one component and an opening on the other, a magnet, or any other appropriate fastening mechanism.
  • the strap 60 may include any appropriate material, such as silicone rubber or polymers.
  • FIGs. 6-8 illustrate a second aspect of a connector, referred to as connector 82.
  • the connector 82 may be used with any of the other components previously described herein, such as the first sheath 6, the second sheath 8, and the imaging device 4. Unless otherwise specified, the connector 82 may have any feature described in connection with connector 10, including exemplary lengths, a hollow interior, interior surfaces shaped to fit around the exterior of an imaging device 4, a lip to mate with the first sheath 6, etc.
  • the connector 82 may include an elongated body portion 84 that extends from the proximal portion 14 of the first sheath 6 to a region adjacent one or more ports 86 of the imaging device 4.
  • the connector 82 may have a portion 88 that protrudes proximally and radially outward from the remaining body portion 84, creating contact with additional surfaces of the imaging device 4.
  • Connector 82 may include a first opening 90 in its upper wall and a second opening 92 in its lower wall.
  • the first opening 90 may extend along a portion of the length of connector 82.
  • the first opening 90 may facilitate insertion of a guidewire through side lumen 22 of first sheath 6 by providing space near the entry to side lumen 22.
  • the opening 90 may also allow the user to access any underlying controls and to view the tubular member 26 and ensure that it is properly inserted into the first sheath 6, in some examples through port 40.
  • the second opening 92 may generally extend from the proximal end to the distal end of the connector 82, as shown in FIG. 7 .
  • the second opening 92 may be connected to a smaller opening 96 configured to receive the tubular member 26 of the imaging device 4.
  • the second opening 92 of connector 82 may include similar features and advantages as the second opening 70 of connector 10 (e.g., flexibility, space for tubular member 26) and may further provide space for other features of the imaging device 4, such as inlet 94.
  • the opening 96 may secure the tubular member 26 with respect to the attachment 2.
  • the connector 82 may include one or more ribs 98 to secure the connector 82 to the imaging device 4.
  • the ribs 98 may protrude from an inner wall of the connector 82 and may extend from a first side of opening 92, around the inner wall of connector 82, to a second side of opening 92.
  • the edge of ribs 98 may be shaped to match the contours of the handle of an imaging device 4, such as the LithoVue scope developed by Boston Scientific Corp. Therefore, when the connector 82 is placed over the handle 24 of an imaging device 4, the ribs 98 may prevent the handle 24 from rotating relative to the connector 82.
  • Two ribs 98 may be located in a central region of the connector 82, with a third rib 98 located near a proximal end of the connector 82.
  • the connector 82 may include one or two ribs 98 or more than three ribs, such as four, five, six, or more ribs 98.
  • FIGs. 9 , 10 , and 11 will be referenced to describe a method, which does not form part of the invention, for using an attachment 2.
  • the method steps may be performed with any of the components described herein (e.g., connector 10 or connector 82), although the attachment 2 of FIG. 1 , with connector 10, is illustrated in the drawings and will be referenced below.
  • the second sheath 8 may be positioned on a distal portion of the first sheath 6 by either inserting the first sheath 6 into the main lumen 46 of the second sheath 8 or by expanding the opening 56 in the wall of the second sheath 8 so that the second sheath 8 can be wrapped around the first sheath 6.
  • the distal end of tubular member 26 may be inserted into proximal portion 14 of first sheath 6 and into the elongated shaft 12.
  • the user may urge the tubular member 26 through the elongated shaft 12 until the distal end of the tubular member 26 aligns with the distal end of the first sheath 6 and/or the distal end of the second sheath 8.
  • the connector 10 may then be connected to the handle 24 of the imaging device 4 by one or both of wrapping a strap 60 around the port protrusion of the handle 24 and securing the strap 60 to the sides of connector 10, or aligning ribs 98 with the appropriate region of the handle 24 and placing the connector onto the handle 24.
  • the tubular member 26 of the imaging device 4 may be placed within an opening 78 in the lip of the connector.
  • the connector 10 may be connected to the first sheath 6.
  • the slots of the lip 34 of the first sheath 6 may be aligned with the protrusions of the lip 66 of the connector 10, and the opening 39 of the first sheath 6 may be aligned with the tubular member 26.
  • the connector 10 and the first sheath 6 may be brought towards each other and twisted relative to each other to fully engage the protrusions with the slots, securing the connector 10 to the first sheath 6.
  • the devices may be used to perform a procedure on a patient, such as a removal of a stone lodged in the ureter 106 or kidney 108.
  • the distal ends of the second sheath 8, first sheath 6, and tubular member 26 may be inserted into the patient's urethra 100 and into the patient's bladder 102 (step 1110).
  • the second sheath 8 may provide additional rigidity and support to the tubular member 26 and the first sheath 6 while passing through the urethra 100 and into the space within the bladder 102.
  • the camera 28 and light 30 of the imaging device may be used to navigate through the urethra 100 and bladder 102 and to locate the ureteral orifice 104 connecting the bladder 102 to a ureter 106 (step 1120).
  • a guidewire may be inserted through either side lumen 48 of the second sheath 8 or side lumen 22 of the first sheath 6 and into the ureter 106.
  • two guidewires may be inserted into the ureter 106, such as a safety guidewire and a working guidewire, with one in each side lumen.
  • the second sheath 8 may be removed from the first sheath 6.
  • a user may grasp the grip 44 and pull the second sheath 8 proximally until the second sheath 8 is outside of the patient (step 1130).
  • the second sheath 8 may remain around the first sheath 6 for the remainder of the procedure, or the second sheath 8 may be removed completely from the first sheath 6 via expansion of the opening 56.
  • the distal end of the first sheath 6, along with the distal end of the tubular member 26, may be inserted into the ureter 106 of the patient by moving the handle 24 of the imaging device 4 towards the patient (step 1140).
  • the smaller diameter of the first sheath 6 relative to the second sheath 8 may allow it to enter the narrow pathway defined by the ureter 106.
  • the shaft 12 of the first sheath 6 Once the shaft 12 of the first sheath 6 is in place within the patient's ureter 106, it may serve as an access sheath for the tubular member 26 or any other tools that may need to be inserted into the ureter 106 or kidney 108.
  • the connector 10 may be disconnected from the first sheath 6 and from the imaging device 4 to release the tubular member 26 and allow it to move relative to the first sheath 6.
  • the tubular member 26 may be withdrawn from the interior of openings 78 and/or 39, and the connector 10 may be twisted relative to the first sheath 6 to release the engaged protrusions and slots.
  • the strap 60 may be released, and the connector 10 may then be pulled away from the imaging device 4, with the handle 24 of imaging device 4 passing through the bottom opening 70.
  • the user may reach through opening 68 in the connector 10, pull the tubular member 26 out of opening 78 of the connector 10 and opening 39 of the first sheath 6, and manipulate the tubular member 26 to either extend its distal end past the distal end of the first sheath 6 or pull its distal end proximally relative to the first sheath 6.
  • the distal end of the tubular member 26 may then be moved relative to the first sheath 6 (step 1150)
  • the tubular member 26 may be used to remove stones lodged in the patient's ureter 106 or kidney 108.
  • Various tools e.g., lasers, baskets, etc.
  • the tools may be used to break up stones and carry them out of the patient.
  • steering control of the tubular member 26 may allow the distal end of the tubular member 26 to navigate tortuous pathways in the ureter 106 or kidney 108 and reach hard-to-access areas to break up and retrieve stones.
  • the tools and/or the tubular member 26 may be removed from the patient one or more times through the first sheath 6.
  • the first sheath 6 may protect the patient's urethra 100, bladder 102, and ureter 106 from damage that could be caused by passing devices into and out of the patient.
  • first sheath 6 and second sheath 8 to access the patient's ureter 106 eliminates the need to use a separate cystoscope to pass through the urethra 100 and bladder 102, locate the ureteral orifice 104, and place a guidewire into the patient's ureter 106 prior to inserting an access sheath and imaging device into the patient's ureter 106. Instead, the first sheath 6 and second sheath 8 are passed through the patient's urethra 100 and bladder 102 once, and the first sheath 6 is passed into the patient's ureter 106 once. All other devices are then passed through the first sheath 6. The second sheath 8 allows the use of a separate cystoscope to be eliminated by providing sufficient rigidity for the tubular member 26 and the first sheath 6 to be passed through the urethra 60 and across the bladder 62.
  • FIG. 12 illustrates another example of an attachment, referred to as attachment 110.
  • Attachment 110 may include a first sheath 6, which may include any features of the first sheath 6 described in connection with other figures, and a connector 112.
  • the first sheath 6 may include two entry ports 118, 120 configured to receive guidewires.
  • the two entry ports 118, 120 may be a feature of any sheath 6 described herein.
  • entry port 118 may be a notch that is connected to the main interior of proximal portion 14 by an opening 122.
  • the guidewire 114 held within entry port 118 may therefore be released from the entry port 118 so that it lies within a main lumen of the proximal portion 14.
  • the guidewire 114 may then travel through the main lumen 20 of shaft 12 or the side lumen 22 of shaft 12.
  • the connector 112 may include any features described in connection with connectors 10 and 82, such as a lip to facilitate attachment to the first sheath 6, or a liner or ribs to facilitate a secure attachment to the imaging device 4.
  • connector 112 may be shaped differently than connectors 10 and 82.
  • connector 112 may include a substantially cylindrical body portion. Similar to the other connectors described herein, an interior of the proximal portion of connector 112 may be contoured to fit securely around the exterior of the imaging device 4.
  • Connector 112 may include one or more elongated openings to allow a user to reach through the openings to manipulate the tubular member 26.
  • the attachment 110 does not include a second sheath.
  • the components of the attachment 110 may be assembled in a similar manner as described in connection with FIGs. 9 and 10 .
  • the tubular member 26 may be inserted into the elongated shaft of the first sheath 6, the connector 112 may be secured to the handle 24 of the imaging device 4, and the connector 112 may be connected to the first sheath 6.
  • a working guidewire 114 may be inserted through an entry port 118 and a safety guidewire 116 may be inserted through an entry port 120.
  • entry port 118 may lead to the main lumen 20 of the first sheath 6, and entry port 120 may lead to a separate side lumen 22 of the first sheath 6.
  • the two guidewires 114, 116 may be inserted into the patient's ureter 106.
  • the connector 112 may be detached from the first sheath 6 and/or the imaging device 4, and the tubular member 26 may be removed from the first sheath 6.
  • the working guidewire 114 then may be released from entry port 118 through an opening 122 between the entry port 118 and the interior of proximal portion 14, so that a proximal portion of working guidewire 114 lies within the main lumen of the interior of proximal portion 14.
  • the distal end of the first sheath 6 may be inserted into the patient's ureter 106 over both guidewires 114, 116, such that the first sheath 6 can serve as an access sheath for the tubular member 26 and other tools used to perform a procedure within the patient's ureter 106 or kidney 108 (similar to methods described above). Accordingly, the tubular member 26 of the imaging device 4 and/or other tools may be inserted back into the first sheath 6 one or more times, as described above.

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Claims (13)

  1. Aufsatz (2; 110) für ein Ureteroskop (4), umfassend:
    eine erste Hülle (6) mit einem proximalen Ende, einem distalen Ende und einem Lumen (20), das sich zwischen dem proximalen Ende und dem distalen Ende erstreckt;
    eine zweite Hülle (8), die um eine Außenseite der ersten Hülle (6) herum angeordnet ist, wobei die zweite Hülle (8) eine Länge aufweist, die geringer ist als eine Länge der ersten Hülle (6); und
    einen Verbinder (10; 112), der mit der ersten Hülle (6) verbunden und eingerichtet ist, mit dem Ureteroskop (4) verbunden zu sein,
    wobei die zweite Hülle (8) ein proximales Ende, ein distales Ende und eine Öffnung (56) in einer Wand der zweiten Hülle (8) aufweist, wobei sich die Öffnung (56) von dem proximalen Ende der zweiten Hülle (8) zu dem distalen Ende der zweiten Hülle (8) erstreckt, wobei die zweite Hülle (8) einen länglichen Schaft (42) mit einer Länge zwischen 50 und 350 mm aufweist,
    dadurch gekennzeichnet, dass
    die Öffnung (56) eingerichtet ist, zu ermöglichen, die zweite Hülle (8) von der ersten Hülle (6) wegzuziehen, ohne dass die erste Hülle (6) proximal relativ zur zweiten Hülle (8) zurückgezogen werden muss, und dass der längliche Schaft (42) der zweiten Hülle (8) radial auswärts von und koaxial zu einem länglichen Schaft (12) der ersten Hülle (6) positioniert ist.
  2. Aufsatz (2; 110) nach Anspruch 1, wobei die erste Hülle (6) einen proximalen Teil (14) mit einem größeren Durchmesser als ein distaler Teil der ersten Hülle (6) aufweist.
  3. Aufsatz (2; 110) nach einem der vorhergehenden Ansprüche, wobei das Lumen (20) ein erstes Lumen (20) ist und die erste Hülle (6) ferner ein zweites Lumen (22) aufweist.
  4. Aufsatz (2; 110) nach einem der vorhergehenden Ansprüche, wobei der Verbinder (10; 112) abnehmbar mit der ersten Hülle (6) verbunden ist.
  5. Aufsatz (2; 110) nach einem der vorhergehenden Ansprüche, wobei der Verbinder (10; 112) umfasst:
    einen Körper mit einem Innenraum, der zum Empfangen eines Teils des Ureteroskops (4) eingerichtet ist; und
    an einer Innenwand mindestens eine Auskleidung oder eine Rippe, wobei die mindestens eine Auskleidung oder die Rippe eingerichtet ist, das Ureteroskop (4) relativ zum Verbinder (10; 112) zu befestigen.
  6. Aufsatz (2; 110) nach Anspruch 1, wobei der Verbinder (10; 112) einen Innenraum aufweist, der eingerichtet ist, einen Teil des Ureteroskops (4) zu empfangen.
  7. Aufsatz (2; 110) nach Anspruch 6, wobei das proximale Ende der ersten Hülle (6) einen größeren Durchmesser aufweist als das distale Ende der ersten Hülle (6).
  8. Aufsatz (2; 110) nach Anspruch 6 oder 7, wobei die zweite Hülle (8) durch Reibschluss an der ersten Hülle (6) befestigt ist und die zweite Hülle (8) abnehmbar mit der ersten Hülle (6) verbunden ist.
  9. Aufsatz (2; 110) nach Anspruch 6 bis 8, wobei der Verbinder (10; 112) eine Öffnung (56) in einer Seitenwand neben einem distalen Ende des Verbinders (10; 112) aufweist, wobei die Öffnung (56) eingerichtet ist, ein rohrförmiges Element (26) des Ureteroskops (4) zu empfangen.
  10. Aufsatz (2; 110) nach einem der Ansprüche 6 bis 9, wobei der Verbinder (10; 112) abnehmbar mit dem proximalen Ende der ersten Hülle (6) verbunden ist.
  11. Aufsatz (2; 110) der Ansprüche 6 bis 10, wobei der Verbinder (10; 112) eine Vielzahl von Rippen aufweist, die von einer Innenwand des Verbinders (10; 112) vorstehen.
  12. Aufsatz (2; 110) der Ansprüche 6 bis 11, wobei der Verbinder (10; 112) eine Silikonauskleidung an einer Innenwand des Verbinders (10; 112) aufweist.
  13. System mit einem Ureteroskop (4) und einem Aufsatz (2; 110) für das Ureteroskop (4) nach einem der vorhergehenden Ansprüche.
EP17704143.1A 2016-01-29 2017-01-26 Aufsatz für ein ureteroskop Active EP3407771B1 (de)

Applications Claiming Priority (2)

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US201662288707P 2016-01-29 2016-01-29
PCT/US2017/015051 WO2017132325A1 (en) 2016-01-29 2017-01-26 Attachment for an imaging device

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EP3407771A1 EP3407771A1 (de) 2018-12-05
EP3407771B1 true EP3407771B1 (de) 2025-12-31

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EP (1) EP3407771B1 (de)
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US12023004B2 (en) 2024-07-02
EP3407771A1 (de) 2018-12-05
US20170215706A1 (en) 2017-08-03
WO2017132325A1 (en) 2017-08-03
US20240298881A1 (en) 2024-09-12
CN108601507A (zh) 2018-09-28
CN108601507B (zh) 2021-11-26
US11330966B2 (en) 2022-05-17
US20220240761A1 (en) 2022-08-04

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